Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The current application has the effective filing date of 03/09/2023 according to the priority on the record.
Claim Objection
Claim 1-20 are objected to because of the following informalities: independent claims 1 and 10 both recite “memory devices comprising instructions”, the Examiner suggests amending to “non-transitory computer memory devices comprising computer executable instructions.” Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): Independent claims 1 and 11 are directed to a device and a method for analyzing patient location activity in connection with a neurostimulation treatment, respectively; and thus, the claims all fall under one of the four patent eligible categories.
Under Step 2(a) prong 1:
Independent claim 1 recites:
A device to analyze patient location activity in connection with a neurostimulation treatment, the device comprising:
one or more processors; and
one or more memory devices comprising instructions, which when executed by the one or more processors, cause the one or more processors to:
receive tagged location data associated with a patient undergoing the neurostimulation treatment, wherein the tagged location data is provided from a patient computing device, wherein the tagged location data indicates a visit of the patient to one or more locations;
identify a location type of the one or more locations, using the tagged location data;
determine characteristics of the visit of the patient at the location type, using the tagged location data; and
control a workflow related to the neurostimulation treatment, based on the characteristics of the visit of the patient at the location type.
Under the broadest reasonable interpretation, the italicized limitations include: receiving tagged location information from a patient (e.g. hospital name); identify a location type of said tagged location information (e.g. medical care); determine a characteristic of the visit using the said tagged location information (e.g. frequency, weather, duration, identify purpose of visit, treatment type, etc.) and then mentally control a workflow (e.g. assign patient to a doctor/treatment type, patient priority etc.). These limitations/steps can be wholly performed by a person via a series of observations, interaction and/or mental determination. For instance, a person can mentally observe the patient’s tagged location information or by speaking to the patient (note: “neurostimulation treatment”, and “patient computing device” are not positively recited features); the person can then mentally determine the location type based on the name of said tagged location information; the person can also observe and mentally determine the characteristics; and finally, the person can mentally determine and control a workflow based on said characteristics. Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas under the mental processes and organized human activities buckets.
As drafted, independent claim 10 recites analogous limitations to claim 1, and it is thus also rejected as reciting one or more abstract ideas under the same rationale.
The dependent claims recite additional limitations with regard to using identifiers for the location type, specifying workflow types, and specifying characteristic types; these features also limitations also fall within the judicial exception of one or more mental processes.
Under Step 2(a) prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claim 1 and 10 further recites: “device”, “processor”, “memory devices comprising instructions”; these bolded limitations fail to practically integrate the recited judicial exception the respective claims because claim elements merely tie the claimed invention to the generic computer field. These claim elements, i.e. “device”, “processor”, “memory devices comprising instructions”, do not practically integrate the judicial exception because these elements do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mathematical concepts grouping or the certain methods of organizing human activity grouping.
Claims 1 and 10 both further recite: “wherein the tagged location data is provided from a patient computer device”, and “control a workflow related to the neurostimulation treatment.” As noted above, the “patient computer device” and “neurostimulation treatment” are not positively recited features. Under BRI, the combination of these features still fails to practically integrate the judicial exception, because these claim elements merely define the field of use of the current claim.
Under Step 2b: The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional claim elements of “device”, “processor”, “memory devices comprising instructions”, and even “patient computing device” and “neurostimulation treatment” are well-understood, routine and conventional activities previously known in the neurostimulation treatment industry as indicated in the following references provided in the Applicant’s own IDS:
DeBates et al. US 2022/0184405 discloses a network-based system for remote health monitoring and treatment of a patient; as shown in Fig. 1. Also see [0066, 0069] with regard to location tracking of patient and clinician.
Pepin et al. US 2021/0065855 A1 discloses a network-based system for remote neurostimulation treatment of a patient as shown in Figs. 1A and 2A. Pepin discloses in [0044] a patient monitoring device that comprises health sensors, and location sensor for monitoring a patient; and in [0084] corresponding environmental factors e.g. location, to a patient’s health state.
Hoyme et al. US 9,265,960B2 discloses an implantable stimulation apparatus that detects a location of the patient, and able to adapted/adjust stimulation protocol, operating mode and/or patient’s access to the apparatus’s capabilities based on a detected location (type); see col.4, ll.20-29.
Accordingly, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims ---1-20 are thus rejected under 35 USC 101 for reciting patent-ineligible subject matter- abstract ideas.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoyme et al. US 9,265,960 B2 (hereinafter “Hoyme”, cited in applicant’s IDS).
Regarding claim 1, Hoyme discloses a device (patient IMD 110/210 and external device 170/270/470, exemplary as shown in Figs. 1-2) to analyze patient location activity in connection with a neurostimulation treatment (see Background and col.2, ll.41-65, IMD is controlled by external device, and external device’s function is tied to location; also see col.1, ll.28-31 IMD is an implantable device with neural stimulation capability), the device comprising:
one or more processors (Fig. 4: control circuit 435 comprises a microprocessor; col.4, ll.11); and
one or more memory devices (Fig.4: memory circuit 440) comprising instructions (col.13, ll.54-col.14, ll.4), which when executed by the one or more processors, cause the one or more processors to:
receive tagged location data associated with a patient undergoing the neurostimulation treatment (patient with IMD), wherein the tagged location data is provided from a patient computing device (external device 170/470), wherein the tagged location data indicates a visit of the patient to one or more locations (col.4, ll.8-10 “the locating circuit 430 determines a location of the external device 470 using the received communication signal”);
identify a location type of the one or more locations, using the tagged location data (col.4, ll.20-29 “the control circuit 435 may determine that the location of the external device is an operating room (OR), an emergency room (ER), a magnetic resonance imaging (MRI) clinic, or a general practice clinic.” The location data from the previous step was used to determine a “location type”, e.g. OR, ER, MRI clinic, hospital, etc.);
determine characteristics of the visit of the patient at the location type, using the tagged location data (col.3, ll.1-36 characteristics include: user interface and/or security level of different personnel to access information and functionality; and also associated with a patient’s condition or need, e.g. clinic for checkup or upload/download information, MRI for scanning, OR for surgery, etc.); and
control a workflow related to the neurostimulation treatment (col.1, ll.28-31 IMD is an implantable device with neural stimulation capability), based on the characteristics of the visit of the patient at the location type (col.4, ll.20-29 “the control circuit 435 can configure (e.g., selectively provide or limit) user access to implantable device features according to the location.” Also see col.7, ll.3-col.8, ll.39 enable/disable different operating mode/features based on the identified location type, e.g. “For various locations, such as an OR, ER, or MRI clinic, it may be desirable to turn one or both of tachyarrhythmia detection and cardioversion/defibrillation therapy off”).
Regarding claim 2, Hoyme discloses the device of claim 1, wherein the tagged location data includes an identifier of the location type, wherein the location type is one of a plurality of defined location types (col.4, ll.20-29 e.g. OR, ER, MRI, clinic, also see Claim 11), and wherein the tagged location data provided from the patient computing device does not include an identifiable geographic location of the one or more locations. (col.4, ll.54-col.5, ll.36 locating circuit 430 uses cellular tower/signal and/or WIFI signal to determine location, these methods do not output “identifiable geographical location”)
Regarding claim 3, Hoyme discloses the device of claim 2, wherein the identifier of the location type is automatically provided by the patient computing device, in response to the patient computing device having detected the visit of the patient to one or more geographic locations associated with the location type. (col.4, ll.44-53, col.8, ll.27-34, approved location types, and associated maps are stored on the device and on a remote server, such that it is automatically identified)
Regarding claim 4, Hoyme discloses the device of claim 3, wherein the location type is a type of medical care location, wherein the location type is categorized as one of a: hospital, clinic, rehabilitation facility, nursing home facility, programming location, or pharmacy, associated with one or more medical professional or service in connection with the neurostimulation treatment; and wherein the identifier of the location type is provided by the patient computing device, in response to selection of the location type by a user of the patient computing device. (See col.4, ll.20-29, operating room (OR), an emergency room (ER), a magnetic resonance imaging (MRI) clinic, or a general practice clinic., also see Claim 11)
Regarding claim 5, Hoyme discloses the device of claim 2, wherein the tagged location data includes an identifier associated with the patient or the patient computing device. (col.3, ll.31-36 approved location identifier, and user identity information; also see col.3, ll.56-64 and col.4, ll.20-29)
Regarding claim 6, Hoyme discloses the device of claim 1, wherein the workflow related to the neurostimulation treatment is a patient interaction workflow to occur with the patient (see col.7, ll.3-col.8, ll.39 enable/disable different operating mode/features based on the identified location type), and wherein the instructions further cause the one or more processors to: generate one or more questionnaires or interaction tasks to provide to the patient based on the characteristics of the visit of the patient at the location type. (col.2, ll.62-67 user interaction of the IMD is tied to location; also see col.3, ll.22-25 “If the external device 270A, 270B is able to determine its location, the user interface of the external device 270A, 270B can be automatically tailored and often simplified to meet the requirements of the location.”)
Regarding claim 7, Hoyme discloses the device of claim 1, wherein the workflow related to the neurostimulation treatment is a caregiver workflow (e.g. nurse; see col.3, ll.26-30, col.7, ll.52-55) to occur with a caregiver or a medical device company representative associated with the patient, and wherein the instructions further cause the one or more processors to: generate one or more alerts to at least one of the caregiver or a medical device company representative based on the characteristics of the visit of the patient at the location type. (col.8, ll.45-53 “The alert may be generated by the external device or by a separate device that communicates the alert to the external device. The external device may then present the alert to the user”; Also see col.9, ll.7-18 regarding additional alert features)
Regarding claim 8, Hoyme discloses the device of claim 1, wherein the workflow related to the neurostimulation treatment is a clinician workflow (e.g. physician, doctor, specialist; see col.3, ll.26-30, col.7, ll.52-55) to occur with a clinician or a medical device company representative associated with the patient, and wherein the instructions further cause the one or more processors to: generate one or more alerts to at least one of the clinician or the medical device company representative based on the characteristics of the visit of the patient at the location type. (col.8, ll.45-53, col.9, ll.7-18, see rejection to claim 7 above)
Regarding claim 9, Hoyme discloses the device of claim 1, wherein the characteristics of the visit of the patient are determined from one or more of:
weather event data associated with weather at the one or more locations;
duration event data associated with a duration of the visit at the one or more locations;
travel event data associated with travel of the patient to or from the one or more locations;
purpose event data associated with a purpose of the visit at the one or more locations (see col.7, ll.3-7, at least visiting OR for surgery can be taken to encompass “purpose event data”); or
social interaction event data associated with interactions occurring between the patient and one or more persons at the one or more locations.
Regarding claim 10, Hoyme discloses the device of claim 1, wherein the instructions further cause the one or more processors to:
determine usage of a neurostimulation program by a neurostimulation device at the location type (col.6, ll.63-66, col.9, ll.34-61, enabling or disabling certain therapy treatments); and
identify a patient state based on the usage of the neurostimulation program and the characteristics of the visit of the patient at the location type (col.2, ll.49-61 and col.5, ll.36-46 heart activity/state, and activity state);
wherein the workflow related to the neurostimulation treatment provides a control to a closed-loop programming therapy of the neurostimulation device based on the identified patient state (col.7, ll.3-col.8, ll.39 enabling and disabling various types of therapy treatments), and
wherein the patient state relates to one or more of: sleep, actigraphy, accelerometry, pain, movement, stress, disease-related symptoms, emotional state, medication state, or activity during use of the neurostimulation program. (col.2, ll.49-61 electrode for detecting heart condition- taken to encompass “disease-related symptoms” in this claim; also see col.5, ll.36-46 accelerometer for detecting physical activity)
Regarding claims 11-20, these claims are rejected by Hoyme under the same rationale as discussed to claims 1-10 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Rosinko et al. US 2022/0199218 A1 see [0574] modifying therapy and/or providing emergency response based on a detected location of a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
January 24, 2026